URIDINE POWDER,ORAL

Clinical Criteria Summary

⇄ This criteria document covers 2 drugs across 2 drug classes.

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Patient exhibits severe or life-threatening toxicity within 96 hours following the end of fluorouracil continuous IV infusion (CIVI) or capecitabine administration.
An overdose of fluorouracil CIVI or capecitabine is suspected, regardless of the presence of symptoms.

Time from end of fluorouracil infusion or last capecitabine dose is greater than 4 days (96 hours). Safety and efficacy of uridine triacetate initiated more than 4 days after end of infusion or last dose has not been established.

Dosage: 10 grams (1 packet) orally every 6 hours for 20 doses (full course), without regard to meals. Do not chew.
Premedication: Ondansetron 8 mg orally, should be given 20 minutes prior to each uridine dose.
Oral Administration: Mix each packet of granules with 3-4 ounces of soft foods (e.g., applesauce, pudding, yogurt) and ingest within 30 minutes. Drink at least 4 ounces of water. Do not chew the granules.
Vomiting Management: If patient vomits within 2 hours of a dose, initiate another complete dose as soon as possible after vomiting episode. Administer next dose at regularly scheduled time.
Missed Dose Management: Administer dose as soon as possible. Give next dose at regularly scheduled time.
NG/G-Tube Administration: Prepare about 4 ounces (100 ml) of a food starch-based thickening product in water and stir until dissolved. Crush contents of a 10 gram packet to a fine powder. Add crushed granules to prepared thickening product and mix thoroughly. After administration, flush tube with water.

While awaiting antidote: Admit patient to inpatient unit and provide supportive care to reduce symptom severity (e.g., IV hydration, electrolyte replacement, treatment of diarrhea, mouth/skin care, granulocyte colony-stimulating factor administration, continuous cardiac monitoring).
Avoid contraindicated medications that might interfere with clearance of fluorouracil or capecitabine (e.g., metronidazole, leucovorin, cimetidine, thiazide diuretics).
Continue close monitoring post-hospitalization for possibly delayed adverse effects, particularly throughout the expected neutrophil nadir. Granulocyte colony-stimulating factors and antibiotics may need to be continued.
Ensure patient/caregiver education about dosing preparation, premedication, schedule, taking a complete course of therapy (20 doses), missed doses, and avoiding potential drug-drug interactions affecting clearance of fluoropyrimidine.

NOT to be used to minimize non-emergent/non-life-threatening toxicity of fluorouracil or capecitabine, as use in this manner may diminish the efficacy of these drugs.
Examples of early onset fluoropyrimidine toxicities include: Gastrointestinal (oral mucositis, diarrhea, anorexia), Cardiac (arrhythmia, chest pain, cardiac arrest), Hematologic (neutropenia, thrombocytopenia), Dermatologic (erythema, desquamation), and Neurologic/CNS (altered mental status, seizures, confusion).
Definition of overdose: Patient receives 10% more than intended dose (>110% of planned dose), or received full dose at an infusion rate 25% more than intended rate.